Understanding Viral Suppression for Newly Diagnosed HIV+ Men to Inform Implementation of TasP and U=U

了解新诊断的 HIV 男性的病毒抑制，为 TasP 和 U=U 的实施提供信息

• 批准号: 10013526
• 负责人: H. Jonathon Rendina
• 金额: $ 94.69万
• 依托单位: HUNTER COLLEGE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-24 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10013526
• 关键词: AIDS prevention; Address; Adherence; Advocacy; American; Back; Behavioral; Biological; Bisexual; Blood; Caring; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials; Complement; Consensus; Continuity of Patient Care; Couples; Data Reporting; Diagnosis; Drops; Early Intervention; Empirical Research; Enrollment; Epidemic; Epidemiology; Event; Financial compensation; Focus Groups; Future; Gays; General Population; Goals; Guidelines; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; HIV diagnosis; Health; Health Personnel; Home environment; Individual; Infection; Intervention; Interview; Lead; Link; Location; Methods; Minority; Modeling; Monitor; Morbidity - disease rate; Movement; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; National Institute of Mental Health; Nature; Newly Diagnosed; Outcome; Patient Self-Report; Pattern; Persons; Phase; Population; Prevention; Provider; Public Health; Qualitative Methods; Research; Resistance; Risk; Risk Factors; Safety; Sampling; Sex Behavior; Sexual Health; Spottings; Stress; Structure; Study models; Surveys; Time; TimeLine; Translating; Treatment Efficacy; United States National Institutes of Health; Viral; Viral Load result; antiretroviral therapy; base; care providers; cohort; critical period; design; high risk; improved; improved outcome; indexing; insight; men; men who have sex with men; men' s group; mortality; psychosocial; recruit; resilience; routine practice; scale up; sexual HIV transmission; sexual minority; social; success; surveillance data; theories; therapy adherence; therapy development; transmission process; uptake; virtual

Project Summary Gay and bisexual men and other sexual minority men (SMM) in the U.S. are burdened by a high and disproportionate rate of HIV infection. Improving outcomes of the HIV Care Continuum through to maintaining viral load (VL) suppression is associated with a significant reduction in the sexual transmission of HIV and significantly better long-term health outcomes. However, little research provides insight into the preventable structural, psychosocial, and behavioral factors that influence durable VL suppression during early infection that can be used in developing effective early intervention strategies. Moreover, the successful implementation of TasP and U=U messaging is a necessary component of the strategy to end the HIV epidemic, but rigorous research is needed to address real-world implementation issues, including safety concerns and perceived barriers among key stakeholder populations. We aim to address these issues with two studies grounded in the Social Ecological Model (SEM) to simultaneously examine both VL suppression and implementation barriers surrounding U=U from multiple levels of influence. Specifically, Aim 1 of the study is to examine time to initial VL suppression and patterns in VL rebound to better understand the dynamic nature of VL suppression and use the SEM along with an intersectional minority stress framework to longitudinally investigate structural, psychosocial, and behavioral factors associated with VL suppression among SMM to better understand risk and resilience. Next, Aim 2 is to examine how adherence and perceived VL status are associated with objective VL status and whether concordance between perceived and actual VL suppression influences sexual risk compensation as captured by event-level sexual behaviors and STI infections. Finally, Aim 3 is designed to understand ongoing barriers to implementing U=U from the perspectives of the three populations critical to its successful implementation among SMM—namely, SMM living with HIV, HIV-negative SMM, and HIV care providers. To do so, Study 1 (Aims 1 and 2) will leverage two LITE cohorts to recruit 250 SMM newly diagnosed with HIV during the course of the studies—we will follow these men for two years immediately following diagnosis, collecting home-based dried blood spot for VL on a monthly basis to examine the dynamic nature of VL suppression. In addition to VL and self-reported data, the study will include objective indicators of adherence and care engagement as well as qualitative interviews. The goal of Study 1 will be to identify risk and resilience factors that influence VL suppression and can be used to guide future intervention development (Aim 1) while simultaneously addressing understudied safety concerns of implementing U=U with regard to unintended risks (Aim 2). In Study 2 (Aim 3), we will use focus groups conducted three times over five years to inform implementation of U=U messaging. Achieving the aims of the proposed study will provide key insights that will be critical for translating to or adapting interventions to enhance their potency and durability and improve the health of SMM living with HIV and curb new infections.

项目摘要 在美国，男同性恋者、双性恋者和其他性少数族裔男性(SMM)承受着高和 不成比例的艾滋病毒感染率。从持续到持续不断地改善艾滋病毒护理的结果 抑制病毒载量(VL)与显著减少艾滋病毒的性传播和 显著改善长期健康结果。然而，很少有研究提供对可预防的 感染早期影响持续性VL抑制的结构、心理社会和行为因素 这可用于制定有效的早期干预策略。此外，成功的实施 TasP和U=U消息传递是结束艾滋病毒流行战略的必要组成部分，但也是严格的 需要进行研究以解决现实世界的实施问题，包括安全问题和感知 关键利益相关者群体之间的障碍。我们的目标是通过两项研究来解决这些问题，这些研究基于 同时考察VL抑制和实施障碍的社会生态模型(SEM) 从多个层面的影响包围U=U。具体地说，这项研究的目标1是检查初始时间 VL抑制和VL反弹模式，以更好地了解VL抑制和VL反弹的动态性质 利用扫描电子显微镜和相交的少数应力框架纵向研究构造， SMM中与VL抑制相关的心理、社会和行为因素以更好地了解风险 和坚韧不拔。接下来，目标2是检查遵从性和感知的VL状态如何与 客观VL状态以及知觉VL抑制与实际VL抑制的一致性是否会影响性 通过事件级别的性行为和性传播感染捕捉到的风险补偿。最后，目标3旨在 从对ITS至关重要的三个群体的角度了解实施U=U的持续障碍 在SMM中成功实施--即艾滋病毒携带者SMM、艾滋病毒阴性SMM和艾滋病毒护理 供应商。为此，研究1(目标1和2)将利用两个精简的队列招募250名新的SMM 在研究过程中被诊断出感染了艾滋病毒-我们将立即对这些人进行两年的跟踪调查 确诊后，每月采集家居干血点进行VL动态检查 VL抑制的性质。除了VL和自我报告的数据，这项研究还将包括以下客观指标 坚持和关怀参与以及定性访谈。研究1的目标将是确定风险 以及影响室上性心动过速抑制并可用于指导未来干预发展的弹性因素 (目标1)同时解决关于以下方面实施U=U的未得到充分研究的安全问题 意外风险(目标2)。在研究2(目标3)中，我们将使用在五年内进行三次的焦点小组来 通知U=U消息的实施。实现拟议研究的目标将提供关键的见解 这对于转化或调整干预措施以增强其效力和持久性以及 改善携带艾滋病毒的SMM的健康，遏制新的感染。